siboneinc

Manufacturing Engineer II

Santa Clara, CA · Mid

Sponsorship not specified$114k-$130kDetected 21 days ago

ExcelSupply ChainERPSolidWorksMechanical DesignFDA RegulatoryMedical DevicesTime Management

About the role

In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing.
The employee has the responsibility to report any instances to their direct supervisor or above.
The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Perform supplier sourcing, evaluation and management in conjunction with quality management systems in the design for manufacturability.
Provide strong verbal and written skills in support for creation and development of standard operation procedures, work instructions, inspections documentation, change controls and visual aids as applicable.
Create and maintain accurate documentation of tool drawings, design concepts and orders, in accordance with the Product Development and Quality Assurance functions.
Collaborate with peers to design and develop supply chain manufacturing processes for new products, enhancements, product changes, and related fixtures and tooling that are consistent with zero defect level.
Support Engineering Change Notice (ECN) and related Material Review Board (MRB) activities including disposition and root cause investigation of non-conforming materials.
Support and adhere to company policies, procedures, goals and objectives, QSR/FDA regulations and evaluate suppliers for good manufacturing practices.
Perform other duties that may be assigned as necessary.
Support the SI-BONE Quality System.
Experience drafting manufacturing change documents

Bachelor's Degree in Manufacturing Engineering or Mechanical Engineering.
Experience in multiple roles and responsibilities conducive of a company in a current state of product development and maturation.
This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior.

Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer
Experienced in designing, analyzing, acquiring and qualifying manufacturing tools and equipment.
Familiar with statistical tools and concepts such as ANOVA and DOE methods.
Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
Excellent time management skills, take initiative to meet deadlines and the ability to prioritize workload and minimal supervision.
The ability to network and interact effectively with a broad range of associates spanning varied disciplines and responsibilities.
Must have a strong passion for product and process excellence and customer satisfaction.
Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems (QAD).

$114,000 - $130,000.
The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge
certifications
and other relevant business and organizational factors.
Supplemental pay: bonus and stock
There are potential risks associated with the iFuse Implant System.

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions.
bonus and stock
It may not be appropriate for all patients and all patients may not benefit.
For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.

This listing is sourced directly from siboneinc's careers page and normalized into a canonical job model.